MAUDE Adverse Event Report: IHEALTH LABS, INC. I HEALTH COVID-19; CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2022

Event Type  malfunction  

Event Description

I ordered covid tests through the government post office site in early (b)(6) 2022.They arrived around (b)(6) 2022.All 8 are set to expire on 7/13/2022.

• Brand Name: I HEALTH COVID-19
• Type of Device: CORONAVIRUS ANTIGEN DETECTION TEST SYSTEM
• Manufacturer (Section D): IHEALTH LABS, INC.; 150c charcot ave.; san jose CA 95131
• MDR Report Key: 14932926
• MDR Text Key: 295477138
• Report Number: MW5110666
• Device Sequence Number: 1
• Product Code: QKP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/02/2022
• 8 Devices were Involved in the Event: 1 2 3 4 5 6 7 8

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Sex: Female